PDLI » Topics » We have a history of operating losses and may never achieve sustained profitability.

This excerpt taken from the PDLI 8-K filed Feb 7, 2005.

We have a history of operating losses and may never achieve sustained profitability.


In general, our expenses have exceeded revenues. As of September 30, 2004, we had an accumulated deficit of approximately $259 million. We expect our expenses to increase because of the extensive resource commitments required to achieve regulatory approval and commercial success for any individual product. For example, over the next several years, we will incur substantial additional expenses as we continue to develop and manufacture our potential products, invest in research and improve and expand our manufacturing, marketing and sales capabilities. Since we or our partners or licensees may not be able to successfully develop additional products, obtain required regulatory approvals, manufacture products at an acceptable cost and with appropriate quality, or successfully market such products with desired margins, we may never achieve sustained profitable operations. The amount of net losses and the time required to reach sustained profitability are highly uncertain.


Our commitment of resources to the continued development of our products will require significant additional funds for development. Our operating expenses may also increase as:


                  some of our earlier stage potential products move into later stage clinical development;


                  additional potential products are selected as clinical candidates for further development;


                  we pursue clinical development of our potential products in new indications;


                  we invest in additional manufacturing capacity;


                  we build commercial infrastructure to market our products in North America;


                  we defend or prosecute our patents and patent applications; and


                  we invest in research or acquire additional technologies, product candidates or businesses.


In the absence of substantial revenues from new agreements with third-party business partners, significant royalties on sales of products licensed under our intellectual property rights, product sales or other uncertain sources of revenue, we will incur substantial operating losses and may require additional capital to fully execute our business strategy.


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